Investigation of Outpatient PUlmonary REhabilitation in Patients Suffering From Post-PE Syndrome: a Randomized Waitlist-controlled Trial - the PURE-PE Study

Medical University of Vienna1 site in 1 country48 target enrollmentJune 1, 2021

ConditionsPulmonary Embolism

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Pulmonary Embolism
Sponsor: Medical University of Vienna
Enrollment: 48
Locations: 1
Primary Endpoint: 6-Minute Walk Test
Status: Recruiting
Last Updated: 7 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This study is a multicenter, parallel, randomized waitlist-controlled trial that primarily focuses on the short-term benefit of outpatient pulmonary rehabilitation (PR) on patients after acute pulmonary embolism.

Patients will be randomized into an intervention and a control group. The intervention group will receive 6 weeks of outpatient PR, while patients in the other treatment arm will serve as a control. After completion of the randomized study, the second arm will undergo PR as well.

Registry

clinicaltrials.gov

Start Date

June 1, 2021

End Date

December 31, 2027

Last Updated

7 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Medical University of Vienna

Responsible Party

Principal Investigator

Stephan Nopp

Principal investigator

Medical University of Vienna

Eligibility Criteria

Inclusion Criteria

•Post-PE syndrome (except patients previously diagnosed with CTEPH) diagnosed by any of the following:
•Post-PE functional impairment criteria
•Post-PE Cardiac Impairment criteria
•Chronic Thromboembolic Disease criteria
•Possibility of starting rehabilitation between 12 and 36 weeks after the initial event of PE

Exclusion Criteria

•CTEPH diagnosis
•Chronic pulmonary diseases: COPD, interstitial lung diseases, asthma (only patients with severe asthma defined as a FEV1 ≤ 80% will be excluded), a statement on COVID-19 was amended due to the pandemic #
•Active cancer
•Pregnancy
•Myocardial infarction or cardiac surgery one year prior to inclusion
•Congenital heart disease, congestive heart failure
•History of stroke
•Any previous inpatient or outpatient PR
•Additional criteria that are absolute contraindications for pulmonary rehabilitation
•Acute and decompensated disease states with severe functional restrictions of various organ systems (e.g. heart, kidney and liver insufficiency, unstable angina pectoris, hemodynamically unstable arrhythmias, acute spinal cord injury, untreated hormonal disorders, acute psychological disorders)